Senior Quality Data Analyst

Posting Date 1 month ago(4/19/2022 10:59 AM)
Requisition ID
2022-10661
Job Location(s)
Bloomington IN United States
Travel
20-30%
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

The Senior Quality Data Analyst at Cook Medical works with subject matter experts, process owners, subsystem leaders, management with executive responsibilities, and IT to execute quality system planning, processes, verification, analysis, and reporting methods while promoting a collaborative atmosphere of quality awareness and continuous improvement.

Responsibilities

• Participate in external audits performed by third parties, such as regulatory authorities.
• Drafting / executing quality plans
• Working knowledge and understanding of COOK Medical Management System Procedures, e.g. CAPA, Nonconformances, Calibration.
• General research, documentation, and file/database maintenance.
• Support quality system activities as they relate to quality data, data analytics, and trending.
• Perform analysis of data in support of quality data trending. Additional analyses of data may be required as needed by the subsystems throughout CINC, e.g. Risk Management, Complaint Handling, CAPA.
• Collaborate with data stewards and process owners to identify data needs and develop dashboards to support processes within COOK’s Quality Management System.
• Maintain electronic files and/or hard copies and manage Management Review meeting minutes and supporting data.
• Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and COOK's Quality Management System, where applicable. Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
• Leadership/mentoring of quality data analysts.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Working knowledge and understanding of ISO 13485 regulations and FDA 21 CFR 820 Quality System Regulations.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualifications

• Minimum 8-10 years relevant experience Quality Assurance or Data Analytics
• Bachelor's Degree or equivalent in a technical discipline or experience of such kind and amount as to provide a comparable background
• Working knowledge of medical device regulations, including pertinent standards and guidances, preferred or demonstrated regulatory knowledge in similarly regulated industry
• Project Management experience preferred

• Auditing certification preferred
• Knowledge of Cook Inc. quality system, associated documentation, and product lines preferred or demonstrated medical device (or similar industry) quality system knowledge
• Experience in statistical and analytical reasoning
• Computer literacy and proficiency
• Data analysis software experience required (e.g. Minitab, JMP, etc.)

 

Physical Requirements:

• Works under general office environment conditions
• Sitting for extended periods
• Utilizes close visual acuity for working with computers and equipment
• Frequently required to stand, walk, and communicate
• Frequently required to lift between 20 and 50 pounds throughout the workday
• Travel up to 30%

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